Summary:
Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of laboratory's humidity log, review of the laboratory humidity records for January 2025, January 2026-March 2026 , review of patient hematology results and interview with the technical supervisor #2, the laboratory failed to ensure the humidity was maintained according to laboratory's humidity log for 49 of 94 days. Findings: 1. Review of the humidity log states "humidity 20-85%." 2. Review of the main laboratory humidity records shows that the laboratory humidity in the main laboratory where the DxH is located was out of range for 27 of 31 days in January 2025. 3. Review of the main laboratory humidity records shows that the laboratory humidity in the main laboratory where the DxH is located was out of range for 22 of 63 days in January 2026-March 2026. 4. Review of patient's hematology results showed the laboratory performs approximately 748 CBC's yearly. 5. Interview with the technical supervisor (TS) #2 on May 27, 2026 at 10:30 AM confirmed the laboratory failed to ensure the humidity was maintained. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --